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. 2020 Oct 22;2020(10):CD008312. doi: 10.1002/14651858.CD008312.pub4

Modi 2016b.

Study characteristics
Methods Study design: pilot RCT
Method of randomisation: permuted block randomisation with block size 2
Setting: new‐onset seizure clinic in a Midwestern children's hospital
Date it was conducted: January 2011‐October 2012
Source of funding: National Institutes of Health
Conflict of interest: the study authors declare no conflict of interest
Participants Inclusion/exclusion criteria: patients with recent diagnosis of epilepsy (within 7 months), aged 2–12 years, no comorbid chronic illnesses requiring routine medications (e.g., diabetes), AED medication in pill or sprinkle form, family residing within 75 miles of the hospital, no significant parent‐reported developmental disorders (e.g. autism), and no prior AED treatment. Children with major developmental disorders were excluded.
Sample size: 50 families. STAR intervention (n = 11) versus TAU (n = 12). Families with high adherence at baseline (n = 22) were not randomised. Of those randomised to the STAR intervention, 2 withdrew prior to treatment initiation and 1 family completed the intervention sessions but was lost to follow‐up.
Age: 7.6 years (SD 3.0)
Gender: 66.0% male
Interventions Type of intervention: educational
Participants involved in 4 face‐to‐face sessions and 2 telephone problem‐solving sessions over 8 weeks
Session 1 addressed deficit in epilepsy knowledge and provided feedback on each family AED adherence over the last 2 weeks. Sessions 2 through 4 aimed to teach families a problem‐solving approach for their identified AED‐adherence barriers.
Outcomes Primary outcome: adherence
Secondary outcomes: epilepsy knowledge; medication self‐management; problem‐solving skills
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk permuted block randomisation with block size 2
Allocation concealment (selection bias) Unclear risk No information on concealment was reported
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No information on blinding was reported
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No information on blinding was reported
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Of those randomised to the STAR intervention, 2 withdrew prior to treatment initiation and 1 family completed the intervention sessions but was lost to follow‐up.
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Insufficient rationale or evidence to permit judgement